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Associate Director, Regulatory Affairs

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

This position will serve as the Clinical/Nonclinical Regulatory lead for a recently approved rare disease program (achondroplasia) with ongoing clinical development and expansive life cycle management plans, including device development and label expansion efforts globally.

This position will serve as the primary liaison for the US FDA. This position will serve as a key contributor to the Global Regulatory Team (GRT); and be responsible for developing and executing the clinical/nonclinical regulatory strategy for the US and providing insights to support global regulatory strategy.  Candidates must have proven expertise in working collaboratively and driving for results in a team setting as well demonstrated skills in communicating with internal and external stakeholders.  

KEY RESPONSIBILITIES:

  • Develop and implement clinical/nonclinical regulatory strategies to support product development, global marketing applications and post-approval activities (eg, NDA maintenance; device development; global label expansion efforts etc.)
  • Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (eg, study execution teams, clinical development team etc.) as appropriate
  • Lead/participate in the planning, creation, review, assembly and submission of regulatory documentation including but not limited to product core dossier, NDA supplements, IND/CTA amendments, meeting requests/briefing books for health authority meetings
  • Serve as primary liaison with US FDA and lead FDA interactions; support global HA meetings by advising on clinical/nonclinical strategy as needed
  • Ensure fulfillment of US clinical and nonclinical PMRs/PMCs, including timely and effective communication of HA feedback (post-marketing study expectations and commitments/milestones) to relevant partner teams and the GRT
  • Collaborate with Regulatory project management to direct the organization and preparation of clear and effective submissions and timings.
  • Prepare and deliver effective presentations for external and internal audience.
  • Provide input to regulatory strategy forums with Regulatory Senior Management teams and represent Regulatory at governance forums.
  • Other duties as assigned

COMPETENCIES

Decision Making and Problem Solving, including an ability to coach and mentor teams to develop creative and novel solutions.

Influence, Cross-Functional Collaboration and Organizational Awareness, including an ability to leverage organizational knowledge, tact, and connections to stakeholders across the organization to extract necessary information quickly and effectively while strengthening inter-departmental relationships.

Agility and Proactivity, such as consistently expecting, driving for and delivering excellence and optimal outcomes.

Leadership, such as skill in building high functioning, effective teams that receive positive feedback from stakeholders.

Communication, including an ability to ensure that employees, at all levels, fully understand their roles in achieving success.

Strategic Thinking and Planning, such as an ability to hold in mind the vision and purpose of the function, along with broader company objectives, when making decisions.

Regulatory Strategy and Frameworks: such as an ability to effectively develop and represent the regulatory position/solution in challenges associated with lifecycle/commercialization.

Scientific Writing for Regulatory Submissions: Able to conduct comprehensive regulatory submission document evaluations including evaluation of the quality and completeness of content.

EDUCATION AND EXPERIENCE

Required Skills:

  • BS degree in life sciences or equivalent; 5-7yrs. experience in Regulatory Affairs in the biotechnology industry
  • Prior experience with global MA filings, license maintenance and life-cycle management preferred
  • Proven ability to manage critical projects as a part of an interdisciplinary team
  • Knowledgeable regarding global regulatory marketing application requirements
  • Proven ability to successfully interact with regulatory authorities
  • Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
  • Thorough understanding of relevant drug development regulations and guidelines
  • Prior experience in a product development role
  • Skilled at developing product approval strategies
  • Exceptional self-management ability; Highly organized with attention to detail
  • Outstanding interpersonal and communication (written and verbal) skills
  • Ability to travel as needed for interactions with Health Authorities or as determined by the business
  • Fluent in English (written and spoken)

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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San Rafael

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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